The RA Specialist works under the responsibility of the Regulatory Affairs Manager Italy. He/she will provide support to the local regulatory activities managed by the Regulatory Affairs Manager Italy in accordance with local regulatory requirements. The position is based in Milan.
Skills
Ability to work independently
Ability to build team relationship and collaborate in a global team environment at all level of the organization.
Good interpersonal communication and organizational skills.
Fluent in English oral and written communication.
Ability to work in a flexible environment to meet all regulatory requirements and business requirements
Good Computer skills (Excel, Word, Power Point)
L' azienda (multinazionale) offre un contratto a tempo indeterminato di 12 mesi.
Principal Activities
Review and submit to AIFA promotional and non-promotional materials in accordance with the Pharmaceutical Lawn. 219/2006
Submission to AIFA for approval of Congresses' sponsorship
Periodic communications to Regions and AIFA on Numbers of HCP visited by RAM
Management and local implementation of Risk Management Plan (education materials, certificate of vaccinations)
Managing translations in Italian of text documents (SmPC, package leaflet. labelling)
Monitor regulatory/pharmaceutical regulations (Regulatory intelligence)
Partner with local pharmacovigilance department in implementing the risk minimization measures
Drafting and updating SOPs under regulatory responsibility
Education
2-3 year experience in pharmaceuticals industry in regulatory affairs
Pharmacist or equivalent education in a life science (biology, chemistry, etc.)
Master in Regulatory Affairs will be a plus
Categoria Professionale: Scientifico / Farmaceutico
Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
Città: Milano (Milano)
Disponibilità oraria:
- Full Time
